MAUDE Adverse Event Report: ETHICON INC. DERMABOND UNKNOWN PRODUCT; ADHESIVE, TOPICAL SKIN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cellulitis (1768); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Pain (1994); Peritonitis (2252)

Event Date 06/20/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6 component code: g07002 ¿ device not returned.Note: this is for off-label use of the dermabond product.If further details are received at a later date a supplemental medwatch will be sent.As no contact information has been provided, no follow up can or will be performed at this time.Should further details be provided, the file will be updated accordingly.This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: 2023 by the american society for gastrointestinal endoscopy https://doi.Org/10.1016/j.Gie.2023.06.026.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported via journal article: title: eus-guided treatment of bleeding peristomal varices (with video).The aim of this study is to assess the safety and efficacy of eus-guided treatment of peristomal varices (pv).20 patients who underwent eus-guided treatment of pv with cyanoacrylate (cya) and/or coils between april 2013 and december 2019 were identified.Intravascular coil placement from our competitor was used and or instillation of.5 to 1.0 ml of 2-octyl cya dermabond was performed until doppler flow was absent or nearly absent in the vessel.Reported complications: peristomal variceal bleeding (n-?) conclusion, eus-guided treatment appears to be a promising intervention to treat refractory pvb.Larger studies are required to confirm these findings and refine procedure technique.

• Brand Name: DERMABOND UNKNOWN PRODUCT
• Type of Device: ADHESIVE, TOPICAL SKIN
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18621104
• MDR Text Key: 334257027
• Report Number: 2210968-2024-00855
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization